Fig. 1: Clinical efficacy of FLC-Vac in combination with ipilimumab plus nivolumab in patients with FLC.

a, A consort diagram of enrolled patients. n values represent the number of patients at each stage of the protocol. The plus–minus sign signifies the safety population and included all patients who received at least one dose of the study drugs. The pilcrow (¶) signifies the evaluable population and included all patients who received at least one dose of vaccine and had baseline and post-treatment T cell measures at 10 weeks. Four patients were not evaluable as patients came off the study before obtaining post-treatment T cell measures at 10 weeks. b, The study schema. c, The change from baseline in the target lesion diameter according to RECIST, version 1.1. d, A spider plot of radiographic responses to treatment. Tumor responses were measured at regular intervals, and the values shown are the largest percentage change in the sum of the longest diameters from the baseline measurements of each measurable tumor. Each line represents one patient. e,f, Kaplan–Meier curves of overall survival (OS) (e) and PFS (f). The 95% CIs for point estimates are shown in red shading. NA, not achieved. g, Radiologic scans of two representative responders (P14 and P2) during FLC-Vac with ipilimumab and plus nivolumab therapy. ITT, intention to treat; ORR, overall response rate; PD, progressive disease; PR, partial response; SD, stable disease; SLD, sum of longest diameters of the target lesions. The orange arrows point to the tumor sites.